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Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
udenafil
placebo
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Subjects aged 18 and over who have any of the following diseases

  • primary Pulmonary Arterial Hypertension
  • secondary Pulmonary Arterial Hypertension caused by connective tissue disease
  • [Phase IIb] Pulmonary Arterial Hypertension caused by congenital heart disease(including Eisenmenger syndrome)

Exclusion Criteria:

  • Subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria
  • BMI(Body Mass Index) < 18.5kg/m2
  • Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>170/100mmHg)
  • Creatinine clearance ≤ 30mL/min
  • History of non-arteritic anterior ischemic optic neuropathy(NAION)

Sites / Locations

  • Seoul National University Hospital
  • Samsung Medical Center
  • Severance Hospital, Yonsei University Health System
  • Chungbook national University Hospital
  • Chungnam National University Hospital
  • Chonnam National University Hospital
  • Pusan national University Hospital
  • Asan Medical Center
  • The catholic univ. of korea Seoul ST. MARY's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

udenafil

placebo

Arm Description

Phase IIa Experimental : Udenafil Dose 1, Dose 2 Phase IIb Experimental : Udenafil

Phase IIa Placebo Comparator : Placebo Phase IIb Placebo Comparator : Placebo

Outcomes

Primary Outcome Measures

Phase IIa - Pulmonary vascular resistance index(PVRI)
Phase IIb - 6-minute walk distance

Secondary Outcome Measures

Full Information

First Posted
January 1, 2012
Last Updated
April 15, 2016
Sponsor
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01553721
Brief Title
Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
Official Title
A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
udenafil
Arm Type
Experimental
Arm Description
Phase IIa Experimental : Udenafil Dose 1, Dose 2 Phase IIb Experimental : Udenafil
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Phase IIa Placebo Comparator : Placebo Phase IIb Placebo Comparator : Placebo
Intervention Type
Drug
Intervention Name(s)
udenafil
Intervention Description
Phase IIa - Udenafil Dose 1, Dose 2(Single dose) Phase IIb - Udenafil(BID)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Phase IIa - placebo Phase IIb - placebo
Primary Outcome Measure Information:
Title
Phase IIa - Pulmonary vascular resistance index(PVRI)
Time Frame
4 hours
Title
Phase IIb - 6-minute walk distance
Time Frame
16weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Subjects aged 18 and over who have any of the following diseases primary Pulmonary Arterial Hypertension secondary Pulmonary Arterial Hypertension caused by connective tissue disease [Phase IIb] Pulmonary Arterial Hypertension caused by congenital heart disease(including Eisenmenger syndrome) Exclusion Criteria: Subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria BMI(Body Mass Index) < 18.5kg/m2 Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>170/100mmHg) Creatinine clearance ≤ 30mL/min History of non-arteritic anterior ischemic optic neuropathy(NAION)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk-Kyung Kim, M.D., Ph.D
Organizational Affiliation
Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Chongno-gu, 28 Yongon-dong
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-Gu, Irwon-Dong 50
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Special City of Seoul
State/Province
Seodaemungu, 250 Seonsanno
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Chungbook national University Hospital
City
Chung-ju
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwang-ju
Country
Korea, Republic of
Facility Name
Pusan national University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The catholic univ. of korea Seoul ST. MARY's hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31202506
Citation
Chang HJ, Song S, Chang SA, Kim HK, Jung HO, Choi JH, Lee JS, Kim KH, Jeong JO, Lee JH, Kim DK. Efficacy and Safety of Udenafil for the Treatment of Pulmonary Arterial Hypertension: a Placebo-controlled, Double-blind, Phase IIb Clinical Trial. Clin Ther. 2019 Aug;41(8):1499-1507. doi: 10.1016/j.clinthera.2019.05.006. Epub 2019 Jun 13.
Results Reference
derived
PubMed Identifier
30808080
Citation
Chang SA, Kim HK, Chang HJ, Kim DK. Acute Hemodynamic Changes after Single Administration of Udenafil in Pulmonary Arterial Hypertension: a Phase IIa Study. Korean Circ J. 2019 Apr;49(4):353-360. doi: 10.4070/kcj.2018.0281. Epub 2018 Dec 10.
Results Reference
derived

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Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

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